Cleared Traditional

K231348 - Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231348 · Roche Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
27d
Days
Class 2
Risk

K231348 is an FDA 510(k) clearance for the Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF. Classified as Alzheimer’s Disease Pathology Assessment Test (product code QSE), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2023 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5840 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K231348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2023
Decision Date June 05, 2023
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QSE Alzheimer’s Disease Pathology Assessment Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5840
Definition In Vitro Test To Determine Whether A Patient Presenting With Cognitive Impairment And Being Evaluated For Ad And Other Causes Of Cognitive Decline Will Test Positive Or Negative For Amyloid Plaques Or Neurofibrillary Tangles As Measured By Pet Imaging Agents.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.